Changes in GERD after gastric banding - relation with esophageal function parameters and other possible predicitve factors
Withdrawn
- Conditions
- complaints of heartburn and regurgitationGastroesophageal reflux disease (GERD)10017977
- Registration Number
- NL-OMON34813
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
- BMI > 40 or > 35 kg/m2 with obesity related comorbidity
- Reflux complaints (assessed with Reflux Disease Questionnaire)
- Positive screening in Nederlandse Obesitas Kliniek for laparoscopic gastric band placement
Exclusion Criteria
- Severly disordered esophageal motility (<20 mmHg mean contraction amplitude in het lower esophagus and less than 50% peristaltic contractions)
- Unability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, theophylline, calcium blocking agents, opioids)
- Endocrine disease causing overweight (hypothyroidism, hypercortisolism)
- Binge-eating disorder or associated eating disorders
- Active drug or alcohol addiction
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Change in reflux symptoms before and 12 months after gastric banding<br /><br><br /><br>Outcome parameter: Reflux disease questionnaire (RDQ) score</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Change in esophageal reflux parameters before and 12 months after gastric<br /><br>banding<br /><br><br /><br>Outcome parameters:<br /><br>- esophageal motility (LES pressure, percentage peristaltic contractions)<br /><br>- refluxtime (percentage of time with pH<4) during 24 hours.<br /><br>- endoscopic findings<br /><br><br /><br>- Development of dysphagia after gastric banding<br /><br><br /><br>Outcome parameter: QLQ-OES 24 dysphagia score</p><br>